RecruitingACTRN12624000289516

Giving Donor Milk Instead of Formula in Moderate-Late Preterm Infants: the GIFT trial

Effect of supplementary pasteurised donor human milk compared with infant formula on length of neonatal hospital stay, morbidity, breastfeeding, growth, development and health care costs in moderate and late preterm babies – a randomised controlled trial


Sponsor

South Australian Health and Medical Research Institute

Enrollment

2,156 participants

Start Date

May 27, 2024

Study Type

Interventional

Conditions

Summary

The GIFT Trial is a randomised, controlled, blinded, parallel group trial to compare the effect of supplementary pasteurised donor human milk versus infant formula on length of neonatal hospital stay, morbidity, breastfeeding, growth, development and health care costs in clinically well pre-term infants born between 32+0 and 36+6, with a birth weight >=1500g and with insufficient maternal breast milk available. The GIFT Trial hypothesises that the use of donor milk instead of infant formula, as a supplement to maternal breast milk, in moderate-late preterm infants will reduce the time spent in hospital after birth.


Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 96 Hourss

Plain Language Summary

Simplified for easier understanding

When premature babies — born between 32 and 37 weeks — need supplementary feeding because their mother's breast milk isn't yet available in sufficient quantities, the standard option is infant formula. However, donated breast milk from other mothers (pasteurised donor human milk) may be a gentler, more natural alternative that helps premature infants leave hospital sooner. The GIFT Trial is comparing donor breast milk versus standard infant formula as a supplement to whatever maternal breast milk is available. The main question is whether using donor milk shortens the length of a premature baby's hospital stay. The study will also look at health outcomes, breastfeeding rates, growth, development, and healthcare costs. Your baby may be eligible if they were born between 32 and 37 weeks gestation, weigh at least 1500 grams, are clinically stable, and do not have enough maternal breast milk available. Babies with metabolic disorders that prevent breastfeeding, or major birth abnormalities requiring surgery, are not eligible. If proven effective, this study could change routine care for thousands of premature babies born across Australia every year.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Pasteurised donor human milk provided by Australian Red Cross Lifeblood. All milk will undergo microbiological screening before and after Holder pasteurisation (30 minutes at 62.5°C) according to Life

Pasteurised donor human milk provided by Australian Red Cross Lifeblood. All milk will undergo microbiological screening before and after Holder pasteurisation (30 minutes at 62.5°C) according to Lifeblood policies. Mother’s own breast milk will always be given first and if supplementary feeds are required, then study nutrition will be used. Feeds will start at 10-15 ml/kg/day, and increasing 10-15 ml/kg/day or as per clinician discretion. Study nutrition will be provided from the day of randomisation for 15 days or earlier if there is sufficient mother’s own breast milk to support the target fluid intake, or the infant is discharged from hospital, to postnatal ward or transferred to another hospital. A research nurse will monitor fluid balance charts to monitor adherence to the study protocol during the intervention phase.


Locations(1)

NSW,QLD,SA,WA, Australia

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ACTRN12624000289516